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Eplex Blood Culture Identification Fungal Pathogen BCID-FP Panel

by Genmark Diagnostics, Incorporated

510(k) K182690

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182690 Date21 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
510(k) Number
FDA Product Code
PEO
Device Class
Class II
Regulation
21 CFR Part 866.3365
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Eplex Blood Culture Identification Fungal Pathogen (BCID-FP) Panel is a qualitative nucleic acid multiplex in vitro diagnostic test. It is intended for use on the Eplex Instrument for the simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture.

This device is used in a laboratory setting to assist in the diagnosis of bloodstream infections. Clinical presentation and additional laboratory testing, such as sub-culturing for organisms not detected by the panel or susceptibility testing, must be considered for final diagnosis. The device has received FDA 510(k) clearance.

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